Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Cryobiopsy for diagnosing mediastinal conditions in Sweden

Official title: Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden

Run by Region Skane · NCT06347939 · Data updated 2026-11-12

This study is testing a new biopsy method to see if it helps doctors better diagnose lung and chest conditions like cancer and infections in patients.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorRegion Skane
Academic / other
Locations2 sites (Lund and 1 other locations)
StatusRecruiting
StartedApril 1, 2024
Main results expectedApril 1, 2026
Study endsDecember 31, 2028
Registry record updatedJuly 17, 2025
Trial IDNCT06347939 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with mediastinal lymphadenopathy greater than 1 cm who require sampling for diagnosis.

Probably not a fit

Patients with severe health conditions such as respiratory failure or high bleeding risk may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness of Endobronchial UltraSound TransBronchial Mediastinal CryoBiopsy (EBUS TBMCB) in diagnosing mediastinal lymphadenopathy, lung cancer, sarcoidosis, lymphoma, and tuberculosis. Participants will undergo EBUS TBNA and EBUS TBMCB procedures, with their biopsy samples compared to assess the diagnostic yield of each method. The study aims to determine how many biopsies are necessary to achieve a definitive diagnosis and to evaluate the added value of combining EBUS TBMCB with EBUS TBNA. Follow-up assessments will occur four weeks post-procedure to monitor for any complications.

Why it matters

Potential benefit: If successful, this study could improve diagnostic accuracy for patients with mediastinal conditions, leading to better-targeted treatments.

How similar studies have gone: Previous studies have shown promising results for EBUS TBMCB, indicating its potential effectiveness in improving diagnostic yield.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Mediastinal lymphadenopathy with a diameter greater than 1 cm.
* Indication for assessment and sampling according to clinical praxis
* Age \> 18 years
* Patients consent to participate in the study.

Exclusion Criteria:

* Hemodynamically instable patient
* Myocardial infarction in the last six weeks prior to participating in the study.
* Life threatening arrythmia
* Respiratory failure and inadequate blood oxygenation despite oxygen supply.
* Tracheal obstruction of high grade.
* High bleeding risk
* Patient not willing to participate in the study
* Patient not speaking swedish and needing translator during the procedure

Where it's running

  • Respiratory medicine and allergy department, Skåne University Hospital
    Lund, Sweden
    Recruiting
  • Norrlands universitetssjukhus
    Umeå, Sweden
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.